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A Prenatal Bonding Intervention for Pregnant Women With Depression

Primary Purpose

Depression, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Baby CHAT
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Prenatal Bonding, Reflective Functioning, Maternal-Foetal Attachment, Mentalisation, Prenatal Depression, Perinatal Depression

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Currently pregnant Aged ≥18 years Between 20- and 34-weeks' gestation Currently experiencing depressive symptoms as identified by the Edinburgh Postnatal Depression Scale (EPDS) Resident in or accessing services in a London borough served by South London & Maudsley NHS Foundation Trust Exclusion Criteria: Experiencing severe depression or current severe co-morbid diagnoses e.g. psychosis Endorse 'yes, quite often' or 'sometimes' on question 10 of the Edinburgh Postnatal Depression Scale (EPDS; in the past 7 days, 'the thought of harming myself has occurred to me') at screening Unable to complete informed consent and the questionnaires in English

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Single-session 90-minute psychoeducational group ("Baby CHAT") delivered antenatally.

Outcomes

Primary Outcome Measures

Change on Maternal Antenatal Attachment Scale (MAAS)
The MAAS (Condon, 1993) is a self-report questionnaire for expectant mothers, designed to assess the maternal-foetal attachment during pregnancy. The scale consists of 19 items on a 5-point Likert scale assessing women's attitudes, feelings and behaviours towards their foetus.

Secondary Outcome Measures

Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ)
The P-PRFQ (Pajulo et al., 2015) is a 14-item self-report questionnaire assessing expectant parents' abilities to think of their foetus as a separate individual with a developing temperament, personality and needs. The scale can be used during the second and third trimester of pregnancy.
Change on Edinburgh Postnatal Depression Scale (EPDS)
The EPDS (Cox, Holden & Sagovsky, 1987) is a 10-item self-report measure used to identify depression in women during the perinatal period. The scale was initially developed to screen for postnatal depression but has also been validated for use in antenatal populations (Murray & Cox, 1990).

Full Information

First Posted
November 9, 2022
Last Updated
September 29, 2023
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05628675
Brief Title
A Prenatal Bonding Intervention for Pregnant Women With Depression
Official Title
Feasibility of a Psychoeducational Group Intervention to Improve Parental Reflective Functioning and Bonding in Prenatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
July 12, 2023 (Actual)
Study Completion Date
July 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to test a group for pregnant women with depression that aims to help them build a stronger relationship with their unborn baby. The main questions it aims to answer are: Is the group acceptable to pregnant women with depression? Is it possible to run this group with pregnant women with depression? Participants will be asked to: attend the group (which lasts 90mins) complete questionnaires before and after the group, and 1 month later
Detailed Description
Depression during pregnancy is a common mental health problem. Pregnant women with depression often continue to feel depressed after their baby is born, which can have several negative effects for both mother and child. For example, depressed mothers can find it harder to build a good relationship with their baby. Existing treatments for depression may not be sufficient to also improve the relationship between mother and baby. Depressed mothers may therefore need more specific help with connecting to their baby. One promising new intervention is Baby CHAT. Baby CHAT is a single-session group that helps expectant parents learn about their unborn baby by viewing moving 4D ultrasound scans. It is believed that this will help parents to build a stronger relationship with their unborn baby. Baby CHAT has already been trialled with parents without any mental health problems, with promising results. This study aims to assess whether Baby CHAT is helpful for pregnant women with depression, collect data to inform future large-scale trials, and to develop the intervention from participants' feedback. The main research question asks: is Baby CHAT acceptable and feasible to deliver with pregnant women with depression? Participants eligible to take part in the project will be people aged ≥18 years who are pregnant, between 20- and 34-weeks' gestation, and currently experiencing depressive symptoms. The project is taking place at an NHS site, with participants recruited from mental health and maternity services and online advertising. Participants will attend an online Baby CHAT group and complete online questionnaires at three time points (before and after Baby CHAT, and at one-month follow-up). The questionnaires will assess participants' relationship with their unborn baby, their ability to imagine their unborn baby as a separate person, and their level of depressive symptoms. The anticipated study end date is May 2023.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Pregnancy
Keywords
Prenatal Bonding, Reflective Functioning, Maternal-Foetal Attachment, Mentalisation, Prenatal Depression, Perinatal Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm repeated measures
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Single-session 90-minute psychoeducational group ("Baby CHAT") delivered antenatally.
Intervention Type
Other
Intervention Name(s)
Baby CHAT
Intervention Description
Baby CHAT is an approximately 90-minute group intervention to be delivered during pregnancy. The group is comprised of psychoeducational material about a baby's social development after birth and while the baby is growing in the womb. Attendees are encouraged to think about when an infant's social development begins and consider whether this occurs before or after birth. Participants are then shown a video clip of Reissland et al.'s (2016) study showing 4D ultrasound images of foetuses mouthing in response to sounds that are presented to them outside the womb. During Baby CHAT, parents are encouraged to reflect on this information in the context of their own baby's development, including their likes and dislikes, routine and personality. The final section of the group involves generating ideas for social activities that parents can try with their baby prior to birth, such as singing to, massaging or reading to their baby.
Primary Outcome Measure Information:
Title
Change on Maternal Antenatal Attachment Scale (MAAS)
Description
The MAAS (Condon, 1993) is a self-report questionnaire for expectant mothers, designed to assess the maternal-foetal attachment during pregnancy. The scale consists of 19 items on a 5-point Likert scale assessing women's attitudes, feelings and behaviours towards their foetus.
Time Frame
Baseline, up to 48-hours post-intervention, 1-month follow-up
Secondary Outcome Measure Information:
Title
Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ)
Description
The P-PRFQ (Pajulo et al., 2015) is a 14-item self-report questionnaire assessing expectant parents' abilities to think of their foetus as a separate individual with a developing temperament, personality and needs. The scale can be used during the second and third trimester of pregnancy.
Time Frame
Baseline, up to 48-hours post-intervention, 1-month follow-up
Title
Change on Edinburgh Postnatal Depression Scale (EPDS)
Description
The EPDS (Cox, Holden & Sagovsky, 1987) is a 10-item self-report measure used to identify depression in women during the perinatal period. The scale was initially developed to screen for postnatal depression but has also been validated for use in antenatal populations (Murray & Cox, 1990).
Time Frame
Baseline, up to 48-hours post-intervention, 1-month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Currently pregnant Aged ≥18 years Between 20- and 34-weeks' gestation Currently experiencing depressive symptoms as identified by the Edinburgh Postnatal Depression Scale (EPDS) Resident in or accessing services in a London borough served by South London & Maudsley NHS Foundation Trust Exclusion Criteria: Experiencing severe depression or current severe co-morbid diagnoses e.g. psychosis Endorse 'yes, quite often' or 'sometimes' on question 10 of the Edinburgh Postnatal Depression Scale (EPDS; in the past 7 days, 'the thought of harming myself has occurred to me') at screening Unable to complete informed consent and the questionnaires in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca C Cockburn
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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A Prenatal Bonding Intervention for Pregnant Women With Depression

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